Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis

Cerebral Palsy, Spastic Clinical Trial

— MegaMuscle  

Official title:

Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649930
• Other study ID #: MegaMuscle
• Secondary ID: 202101520210088A
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: September 2025

Study information

• Verified date: November 2022
• Source: Amsterdam UMC, location VUmc
• Contact: Marjolein M van der Krogt, Dr.
• Phone: (20)4440789
• Email: m.vanderkrogt[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation in society. There are several treatments aimed to increase the range of motion of the joint by lengthening the muscle, for example botulinum toxin injections. However, these treatments can have a weakening effect on the muscle due to deconditioning from immobilization and due to paralysis. In rehabilitation centers in the Netherlands functional power training (MegaPower) is offered to children with SP who want to walk and run better. It has been shown that this training improves calf muscle strength and performance during functional walking tests. However, the effect of MegaPower training on muscle morphology (i.a. muscle volume and length) is still unknown. Therefore, the aim of this study is to assess the effect of MegaPower training on the muscle morphology of the medial gastrocnemius in children with SP using 3D ultrasonography. It is expected that MegaPower training results in an increase of muscle volume as well as elongation of the muscle belly. Muscle volume could increase due to hypertrophy of the muscle fibers induced by the training, which could elongate the muscle belly length due to the pennate structure of the medial gastrocnemius. A double-baseline design will be applied for this study with three different measurement times (T0-T1-T2) to compare the training period (12 weeks) with a period (12 weeks) of usual care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Gross Motor Function Classification System I-III
• Children should be able to lie on their stomach for min. one minute
• Children should be able to follow instructions.

Exclusion Criteria:

• Received (one of) the following interventions within six months:
• Casting
• Botulinum toxin type-A injections
• Orthopedic surgery.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Paresis

Intervention

Other:
• Functional power training
The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks.

Locations

Country	Name	City	State
Netherlands	Reade	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Reade Rheumatology Research Institute, University Ghent

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical file information	Age, gender, GMFCS-level, medical history	12 weeks before start training (week -12)
Primary	Muscle volume in dm^3		12 weeks before start training (week -12)
Primary	Muscle volume in dm^3		At the start of training (week 0)
Primary	Muscle volume in dm^3		At the end of the training (week 12)
Primary	Muscle belly length in mm		12 weeks before start training (week -12)
Primary	Muscle belly length in mm		At the start of training (week 0)
Primary	Muscle belly length in mm		At the end of the training (week 12)
Primary	Tendon length in mm		12 weeks before start training (week -12)
Primary	Tendon length in mm		At the start of training (week 0)
Primary	Tendon length in mm		At the end of the training (week 12)
Primary	Fascicle length in mm		12 weeks before start training (week -12)
Primary	Fascicle length in mm		At the start of training (week 0)
Primary	Fascicle length in mm		At the end of the training (week 12)
Secondary	Isometric muscle strength of the medial gastrocnemius	Measured with a hand-held dynamometer in Nm.	At the start of training (week 0)
Secondary	Isometric muscle strength of the medial gastrocnemius	Measured with a hand-held dynamometer in Nm.	At the end of the training (week 12)
Secondary	Dynamic muscle strength	Standing heel-rise test on one leg. Measured in amount of repetitions.	At the start of training (week 0)
Secondary	Dynamic muscle strength	Standing heel-rise test on one leg. Measured in amount of repetitions.	At the end of the training (week 12)
Secondary	Functional Strength Measure (FSM)	Measurement for lower and upper limb functionality.	At the start of training (week 0)
Secondary	Functional Strength Measure (FSM)	Measurement for lower and upper limb functionality.	At the end of the training (week 12)
Secondary	1-minute-walk-test	Distance (m) covered in 1 min walking.	At the start of training (week 0)
Secondary	1-minute-walk-test	Distance (m) covered in 1 min walking.	At the end of the training (week 12)
Secondary	10m Shuttle run test	Measured in amount of steps reached.	At the start of training (week 0)
Secondary	10m Shuttle run test	Measured in amount of steps reached.	At the end of the training (week 12)
Secondary	6x15m sprint	Measured as average time (s) over 6x15 m sprint.	At the start of training (week 0)
Secondary	6x15m sprint	Measured as average time (s) over 6x15 m sprint.	At the end of the training (week 12)
Secondary	Ankle range of motion	Maximal dorsiflexion in degrees manually measured with a goniometer.	At the start of training (week 0)
Secondary	Ankle range of motion	Maximal dorsiflexion in degrees manually measured with a goniometer.	At the end of the training (week 12)
Secondary	Body weight in kg		12 weeks before start training (week -12)
Secondary	Body weight in kg		At the start of training (week 0)
Secondary	Body weight in kg		At the end of the training (week 12)
Secondary	Body length in m		12 weeks before start training (week -12)
Secondary	Body length in m		At the start of training (week 0)
Secondary	Body length in m		At the end of the training (week 12)
Secondary	Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	12 weeks before start training (week -12)
Secondary	Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	At the start of training (week 0)
Secondary	Lower leg length in mm	Measured from the lateral malleolus and tibial plateau.	At the end of the training (week 12)